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18F-VM4-037 PET Imaging in Renal Cell Carcinoma

NCT01712685Phase 2

Key facts

Status: Terminated
Start: Oct 2012
Primary completion: Aug 2013
Countries: 1
Sponsor: National Cancer Institute
Modality: Small Molecules

Drugs: [18F]VM4-037
Conditions: renal cell carcinoma (RCC)

Overview

Phase 2, open-label, single-arm trial of [18F]VM4-037 in renal cell carcinoma (RCC), sponsored by National Cancer Institute. Primary endpoint: Level of Uptake of 18F-VM4-037 in Tumor and Non Tumor Tissues, Calculated as Standardized Uptake Values at 58 days. Started Oct 2012; status: terminated.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Renal Cell Carcinoma Cohort
Single group of patients with RCC undergoing PET/CT imaging with 18F-VM4-037.

Who it enrols

Adults with confirmed primary RCC (>= 2.5cm) or metastatic RCC (>= 1cm) scheduled for surgery or biopsy, with adequate organ function and ECOG 0-2.

Endpoints

Primary

Level of Uptake of 18F-VM4-037 in Tumor and Non Tumor Tissues, Calculated as Standardized Uptake Values58 days

Secondary

Number of Participants With Adverse Events58 days
Mean Standard Uptake Value for All Target Lesions60 minutes post injection
Mean Standard Uptake Value for Primary Clear Cell Renal Carcinoma60 minutes post injection
Mean Standard Uptake Value for Normal Kidney60 minutes post injection
Number of Participants With a Mutation of the Von Hippel-Lindau Gene14 months
Distribution Volume Ratio for the Primary Kidney Lesions60 minutes post injection
Time to Peak Activity Derived From Time Activity Curve45 minutes post injection
Kinetic Rate Constant60 minutes post injection

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